Breast Cancer Clinical Trial

Lifestyle, Exercise, and Nutrition Study Early After Diagnosis

Summary

The proposed study is a randomized trial evaluating the impact of a dietary and physical activity guidelines intervention vs. usual care on adherence to breast cancer treatments, body composition, and changes in biomarkers in 172 women newly diagnosed with breast cancer scheduled to receive neoadjuvant or adjuvant chemotherapy.

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Full Description

Currently the Department of Health and Human Services, the American Cancer Society and others provide diet and exercise guidelines for cancer survivors. Many women with breast cancer do not follow these guidelines, and also elect to delay concerted efforts toward following them until active treatment is complete. However, adoption of these recommended lifestyle behaviors soon after diagnosis may prevent adverse changes in body composition and breast cancer biomarkers and may even improve the efficacy of treatment resulting in improved breast cancer prognosis. Further, by increasing our understanding of the mechanisms mediating the association between lifestyle behaviors and breast cancer survival, this study will improve our knowledge of how changes in diet and physical activity influence breast cancer outcomes. Lastly, guidelines for breast cancer survivors also overlap with those for diabetes and cardiovascular disease (CVD) prevention, the latter being a common cause of breast cancer mortality.

The proposed study will examine, in 172 women newly diagnosed with Stage I-III breast cancer who are not practicing the dietary and lifestyle guidelines, and who are scheduled to receive neoadjuvant or adjuvant chemotherapy, the effect of a 1-year dietary and physical activity guidelines intervention vs. usual care on the following breast cancer outcomes measured before beginning chemotherapy (Time 0), post chemotherapy (Time 1), at one-year post-diagnosis (Time 2), and at two years post-diagnosis (Time 3): adherence to treatment, and changes in biomarkers, body composition, and quality of life.

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Eligibility Criteria

Inclusion Criteria:

Diagnosed with Stage I-III breast cancer
Scheduled to receive neoadjuvant or adjuvant chemotherapy
Physically able to walk
Able to complete forms, understand instructions and read intervention book in English
Agrees to be randomly assigned to either intervention or usual care group

Exclusion Criteria:

Women who have completed their 2nd chemotherapy
Women already practicing dietary or physical activity guidelines
Are pregnant or intending to become pregnant in the next year
Recent (past year) stroke/myocardial infarction or congestive heart failure/ejection fraction < 40%
Presence of dementia or major psychiatric disease
Non-English speaking

Study is for people with:

Breast Cancer

Estimated Enrollment:

173

Study ID:

NCT03314688

Recruitment Status:

Active, not recruiting

Sponsor:

Yale University

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There are 2 Locations for this study

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Yale University
New Haven Connecticut, 06510, United States
Dana Farber Cancer Center
Boston Massachusetts, 02215, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

173

Study ID:

NCT03314688

Recruitment Status:

Active, not recruiting

Sponsor:


Yale University

How clear is this clinincal trial information?

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